Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, Non-Small Cell Lung Cancer, or Mesothelioma

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Innovive Pharmaceuticals
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00398138
First received: November 9, 2006
Last updated: February 2, 2016
Last verified: February 2016
Results First Received: December 22, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lung Cancer
Malignant Mesothelioma
Myelodysplastic Syndromes
Primary Peritoneal Cavity Cancer
Interventions: Biological: WT-1 analog peptide vaccine
Biological: incomplete Freund's adjuvant
Biological: sargramostim
Genetic: polymerase chain reaction
Other: flow cytometry
Other: immunoenzyme technique

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Vaccine

Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.

WT-1 analog peptide vaccine


Participant Flow:   Overall Study
    Vaccine  
STARTED     12  
COMPLETED     10  
NOT COMPLETED     2  
Adverse Event                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Vaccine

Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.

WT-1 analog peptide vaccine


Baseline Measures
    Vaccine  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     5  
Gender  
[units: participants]
 
Female     2  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Safety   [ Time Frame: 2 years ]

2.  Primary:   Immune Response   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Peter Maslak, Attending
Organization: Memorial Sloan Kettering Cancer Center
phone: +1212-639-5518
e-mail: maslakp@mskcc.org


Publications of Results:

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00398138     History of Changes
Other Study ID Numbers: 06-085
P30CA008748 ( US NIH Grant/Contract Award Number )
P01CA023766 ( US NIH Grant/Contract Award Number )
MSKCC-06085
Study First Received: November 9, 2006
Results First Received: December 22, 2015
Last Updated: February 2, 2016
Health Authority: United States: Food and Drug Administration